Treats migraine with or without aura. NDA 208223, held by Tonix Meds. Sumatriptan Succinate.
As of Nov 13, 2026, NDA 208223 (Zembrace Symtouch (Autoinjector)), held by Tonix Meds, was first approved by FDA on Jan 28, 2016, with 2 approved supplements and 0 published complete response letters.
ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults. ZEMBRACE SymTouch is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. Not indicated for the prophylactic therapy of migraine. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
| Jun 10, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zembrace Symtouch (Autoinjector)EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) · solution;subcutaneous | Sumatriptan Succinate | RxReference drug |
| Jun 10, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Jan 28, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
